Lonza, a leading global cell and gene therapy manufacturer, and Agilent Technologies, a leader in life sciences analytics, diagnostics, and applied chemical markets, today announced a collaboration that has the potential to transform the way personalized cell therapies are manufactured and realized.
Product quality and consistency are significant challenges for cell therapy manufacturing due to the complexity of the products and patient-specific variability. In addition, cell therapy products are largely defined by the process, which means minor changes during manufacturing could potentially cause major changes in the quality and efficacy. In-process controls and analytics are critically important in ensuring a consistent drug product, even in the presence of such variability, to provide real-time information on Critical Quality Attributes (CQA) throughout the manufacturing process and for quality control (QC) release testing.
By understanding the CQAs required for a potent and persistent cell therapy product, the manufacturing process can be “directed” in real-time. This is especially critical in autologous cell therapies due to the high variability of patient starting material.
This collaboration will integrate Agilent’s current and new analytics technologies and techniques into the Cocoon® Platform’s cell therapy manufacturing workflow to explore current and assess new CQAs required for the release of the therapeutic to the patient. By integrating Agilent analytical technologies both at-line and in-line within the Cocoon® Platform automated manufacturing workflows, manufacturers will be able to ensure that in-process controls and analytics can be employed on-demand to deliver a more consistent drug product.
Nicholas Ostrout, Senior Director, Business Strategy & Implementation, Personalized Medicine, Lonza, commented: “The integration of Agilent’s analytical technologies into the Cocoon® Platform’s manufacturing workflow has the potential to transform the way cell therapies are manufactured and released. The collaboration with Agilent is complementary to our long-term goals for the Cocoon® Platform and we are excited about this synergistic relationship. There is a huge opportunity through this partnership to determine what the ideal critical quality attributes are for manufacturing the most effective cell therapy, and drive the manufacturing, optimally in real-time, to meet those criteria.”
David Ferrick, Associate Vice President of New Market Development for Agilent’s Cell Analysis Division, added: “Merging Agilent’s unique cell analytics and engineering expertise with Lonza’s advanced biologics manufacturing capabilities will ensure the efficacious and sustainable development of autologous cell-based therapies. This timely combination is well-positioned to deliver the first fit-for-purpose solution for scaled manufacturing of autologous cell therapies.”
The Cocoon® Platform is an automated and closed platform for patient-scale cell therapy manufacturing, designed to overcome manufacturing challenges associated with patient-scale personalized medicines. The Cocoon® Platform is commercially available and gaining global traction as the go-to manufacturing platform for patient-scale cell therapies.